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WO1995003017A1 - Procede de coloration oculaire servant a modifier la couleur de l' ×il - Google Patents

Procede de coloration oculaire servant a modifier la couleur de l' ×il Download PDF

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Publication number
WO1995003017A1
WO1995003017A1 PCT/US1994/008242 US9408242W WO9503017A1 WO 1995003017 A1 WO1995003017 A1 WO 1995003017A1 US 9408242 W US9408242 W US 9408242W WO 9503017 A1 WO9503017 A1 WO 9503017A1
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WO
WIPO (PCT)
Prior art keywords
layer
deeper
corneal
lamellae
recited
Prior art date
Application number
PCT/US1994/008242
Other languages
English (en)
Inventor
Allan M. Robbins
James V. Aquavella
Original Assignee
Robbins Allan M
Aquavella James V
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Robbins Allan M, Aquavella James V filed Critical Robbins Allan M
Publication of WO1995003017A1 publication Critical patent/WO1995003017A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/013—Instruments for compensation of ocular refraction ; Instruments for use in cornea removal, for reshaping or performing incisions in the cornea
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F9/00802—Methods or devices for eye surgery using laser for photoablation
    • A61F9/00804—Refractive treatments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F9/00802—Methods or devices for eye surgery using laser for photoablation
    • A61F9/00817—Beam shaping with masks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00861—Methods or devices for eye surgery using laser adapted for treatment at a particular location
    • A61F2009/00872—Cornea

Definitions

  • a process for changing the color of an eye In the first step of the process, the epithelium covering the cornea of the eye is removed. In the second step of the process, water-insolu ⁇ ble stain is contacted with one or more layers of the cornea below the basement membrane. In the third step of the inven ⁇ tion, the layer of the cornea is contacted with laser energy to create punctures of a predetermined size.
  • Figure 1 is a horizontal sectional view of a human eyeball
  • Figure 2 is a sectional view of the cornea of a human eyeball
  • Figure 3 is a flow diagram of a preferred process of the invention.
  • Figure 4 is a front view of a cornea with a center point marked thereon.
  • Figure 5 is a front view of the marked cornea of Fig ⁇ ure 4 with a central clear zone marked thereon.
  • Figure 6 is a front view of the marked cornea of Fig ⁇ ure 5 with a multiplicity of radial incisions made therein;
  • Figure 7 is preferred embodiment of an apparatus which may be used in applicant's process
  • Figure 8 is a top view of a mask which may be used in one of the preferred processes illustrated in Figure 3;
  • Figure 9 is a side view of a device containing a mul ⁇ tiplicity of needles which may be used in conjunction with the apparatus of Figure 7;
  • Figure 10 is a front view of the device of Figure 9.
  • Figure 11 illustrates a series of laser beams in a specified pattern impacting the stained layer of a cornea.
  • Figure 1 is a horizontal section of the human eyeball 10.
  • the eyeball 10 is a spherical, orbital sense organ that receives light and transmits visual information to the central nervous system. It is composed of three major layers (corneosclera, uvea, and retina) enclosing the agueous, lens, and vitreous.
  • outer clear layer 22 of eye 10 is comprised of the anterior epithel ⁇ ium layer 12 (hereinafter referred to as the "epithelium”), Bowman's membrane 14, the substantia propia 16 (hereinafter referred to as the "corneal stroma”), the Descemet's membrane 18, and the endothelium 20. Together these areas collectively comprise cornea 22.
  • FIG. 2 is a microscopic cross-sectional view of cornea 22. Referring to Figure 2, it will be seen that the exterior layer of cornea 22 is comprised of epithelium 12.
  • the epitheli ⁇ um 12 which is often also referred to as the “corneal epi ⁇ thelium, " is comprised of multiple layers of cells that form the most superficial layer of the cornea; it rests on Bow ⁇ man's membrane 14.
  • the corneal epithelium is of uniform thickness (50 to 90 microns) with five to seven layers of nucleated cells di ⁇ vided into a superficial zone, usually formed by to or three layers of flat sguamous cells, a middle zone, formed by two or three layers of polyhedral wing cells, and a basal zone consisting of a single row of columnar cells.
  • basement membrane 24 is a thin membrane layer of connective tissue found at the base of every type of epitheli ⁇ al cell; it helps hold the cells in place.
  • the basement membrane 24 is a pro ⁇ duct of the basal epithelial cells, approximately 30 to 60 microns wide.
  • the posterior border of the basement membrane 24 often projects into the Bowman's zone 14 and consists of finely packed filaments embedded in a homogeneous matrix which can be regenerated by the basal cell layer after injury.
  • Bowman's membrane 14 which is one of the five corneal layers located just under the epithelium and above the corneal stroma 16.
  • the corneal stroma 16 represents at least about 90 percent of the corneal thickness.
  • the Bowman's zone 14, which is the most anterior zone of the corneal stroma 16, possesses resilient and mechanical proper ⁇ ties which are due to an interdigitating arrangement of colla ⁇ gen fibrils.
  • the corneal stroma 16 is comprised of bundles of collagen fibers which are arranged in layers (or lamellae) separated by a ground substance of muco- polysaccharides.
  • the layers are straight, but in the anterior region they may vary from a single row to several rows.
  • collagen fibers are parallel to each other, but fibrils in one lamella which traverse the entire cornea cross nearly at right angles to those in an adjacent lamella. This three- dimensional array acts as a diffraction grating.
  • FIG 3 is a flow diagram of a preferred process within the scope of this invention. Referring to Figure 3, and in the preferred embodiment illustrated therein, it will be seen that, in step 26 of this process, the epithelium 12 of cornea 22 is preferably anesthetized.
  • a topical anesthetic is applied to epithelium 12.
  • topical anesthetics such as, e.g., cocaine hydrochloride, proparacaine hydrochloride (also known under the trade names of "AK-TAINE,” “ALCAINE,” and “OPTHAINE, " ), tetracaine hydro ⁇ chloride (also known under the trade names “ANACEL” and “PONTOCAINE” ) , and the like.
  • topical anesthetics are described on page 10 (see Table 14) of Edward R. Barnhart's “Physicians' Desk Reference for Ophthalmology,” 18th Edition (Medical Economics Company Inc., Oradell, New Jersey, 1990).
  • epithelium 12 such as, e.g., procaine, tetracaine, hexylcaine, bupivacaine, lidocaine, mepivacaine, prilocaine, etidocaine, and the like; see, e.g., Table 15 of said page 10 of Barnhart's "Physician's Desk Reference for Ophthalmology," supra.
  • a re ⁇ gional anesthetic to epithelium 12 such as, e.g., procaine, tetracaine, hexylcaine, bupivacaine, lidocaine, mepivacaine, prilocaine, etidocaine, and the like; see, e.g., Table 15 of said page 10 of Barnhart's "Physician's Desk Reference for Ophthalmology," supra.
  • Such regional anesthetic may be ap ⁇ plied by peribulbar or retrobulbar injection.
  • the visual axis is preferably marked in step 28; alternatively, as described below, another desired center point may be marked.
  • the visual axis (which is often also referred to as the "line of fixation,” or the “primary line of sight,” or the “principal line of direction,” or the “visual line”), or any other desired center point, may be marked by conventional means.
  • line of fixation or the "primary line of sight,” or the “principal line of direction,” or the “visual line”
  • any other desired center point may be marked by conventional means.
  • the center of the patient's pupil is marked instead by a process in which the area and geometry of the iris are of paramount importance.
  • the center of the patient's pupil may be marked by a visual process in which calipers may be used to measure the maximum and minimum dimensions of the pupil and the geometric center is thereafter calculated and marked.
  • Figure 4 is a front view of a cornea 22 in which cen ⁇ ter point 23 has been marked.
  • Figure 5 is a view of the cornea of Figure 3A in which a corneal clear zone 25 has been marked on cornea 22.
  • the corneal clear zone is the area of the cornea which will not be affected by the surgical procedure.
  • Figure 6 which illustrates the radial incisions 27 which are commonly made in radial keratoto y (“RK”), the corneal clear zone 25 will be marked to demarcate the area which is not to be treated.
  • the corneal clear zone 25 will vary from patient to patient, depending upon the age of the patient, the patient's pupil size, whether other refractive surgery (such as radial keratotomy) is to be performed, and other factors.
  • the corneal clear zone 25 is a substantially circular area with a diameter of from about 2 to about 8 millimeters and, preferably, from about 2 to about 5 millimeters. In one preferred embodiment, the diameter of the corneal clear zone 25 is from about 3 to about 4 millimeters.
  • the size of the corneal clear zone will be determined based upon the size of the patient's pupil and the degree of the color change desired.
  • the corneal clear zone will generally be a substantially circular shape with a diameter ranging from about 2 to about 5 millimeters.
  • a trephine is a surgical cutting tool that is capable of making a circular hole in tissue. See, e.g., United States patents 5,084,059, 4,913,143, 4,796,623, 4,336,805, and the like, the disclosure of each of which is hereby incorporated by reference into this specification.
  • trephine sold by the Storz Ophthalmic Instruments of 3365 Tree Court Industrial Blvd., St. Louis, Mo. 63122 (see the 24th edition of the "Storz Ophthalmic In ⁇ struments" catalog which was published in 1988).
  • trephine sold under the trade name of "PATON SEE-THROUGH TREPHINE,” model number E3806 (see page 256 of said Storz catalog) .
  • PATON SEE-THROUGH TREPHINE model number E3806
  • CASTRO- VIEJO CORNEAL TRANSPLANT TREPHINE model E3100 (see page 257 of the Storz catalog) .
  • the corneal clear zone is to be masked
  • a masking material which is adapted to fit over the corneal clear zone over such zone.
  • a suitably sized contact lens over such corneal clear zone.
  • the contact lens used consists essentially of polymethylmethacrylate (PMMA).
  • PMMA polymethylmethacrylate
  • Storz intraocular lens implant manufac ⁇ tured by Storz/Coburn Company of 1365 Hamlet Avenue, P.O. Box 2498, Clearwater, Florida 33618.
  • Other suitable masking devices will be readily apparent to those skilled in the art.
  • the mask consist essentially of clear material so that the surgeon can determine whether the dye used is in the desired area(s) and does not invade the corneal clear zone.
  • the masking means may be disposed over the corneal clear area, contiguous therewith. Alternatively, one may removably adhere the masking means to the corneal clear zone by conventional adhesive means.
  • adhesive means e.g. one may use "AM- VISC PLUS” for this purpose; "AMVISC PLUS” is a sterile, nonpyrogenic solution of sodium hyaluronate which is sold by the IOLAB Corporation of 500 Iolab Drive, Claremont, Califor ⁇ nia.
  • methylcellulose which is sold under the trade name of "OCCUCOAT" by the Storz company.
  • the area of the epithelium 12 outside of the corneal clear zone may be removed by conven ⁇ tional means.
  • both the ultraviolet wavelength lasers as well as the frequency coupled yttrium aluminum garnet (“yag”) lasers and the picosecond lasers have demonstrated an ability to ablate tissue and leave behind a smooth surface.
  • the unwanted portion of epithelium 12 is removed by curettage.
  • a curette which is also often referred to as a "curet" is an instrument, shaped like a spoon or scoop, for scraping away tissue.
  • Curettes are well known to those skilled in the art and are disclosed, e.g., in United States patents 5,090,907, 5,069,224, 5,024,600, 4,932,957, 4,838,899, 4,785,796, 4,777,947, 4,651,735, 4,641,662, 4,572,180, 4,044,770, 3,889,657, 3,670,732, 3,635,222, 3,542,031, 3,502,082, 3,491,747, D318,117, D312,310, and D275,127; the entire disclosure of each of these United States patents is hereby incorporated by reference into this patent application.
  • cur ⁇ ette which may be used in applicant's process is described on page 38 of the aforementioned Storz catalog as "HEATH CHALA- ZION CURETTE,” model number E0801.
  • the basement membrane 24 is also preferably removed.
  • the epithelium 12 is readily removed by mechanical abrasion; and the basement membrane 24, which is the bottom of the epithelium 12, is also readily removed by such means.
  • the Bowman's membrane 14 is substantially more resilient, it generally will not be removed by mere mechanical abrasion.
  • the unmasked and/or unmarked portions of the cornea 22 will preferably have been abraded down to the Bowman's membrane 14 of such stroma.
  • the exposed areas of the Bowman's membrane then be stained in staining step 36.
  • a stain which will selectively stain only the Bowman's membrane 14 and/or have a substantially higher affinity for the Bowman's membrane 14.
  • step 26 after the anesthetic has been applied to epithelium 12 (in step 26), or after other suitable means have been taken to minimize the patient's discomfort, all or substantially all of the epithelium 12 is removed by the conventional means described elsewhere in this specifica ⁇ tion in step 38. Thereafter, the entire exposed corneal stroma surface (such as the Bowman's membrane 14) is then stained in step 40. Alternatively, portions of the exposed corneal stroma may be punctured with a multiplicity of needles and stained in step 41.
  • a portion in the center of such stained stroma surface which corresponds in size to the desired clear corneal area (and generally has a diameter of from about 2 to about 8 millimeters) is treated by laser means to remove the stain.
  • laser means to remove the stain.
  • step 42 a suitable portion of the stained tissue may be excised.
  • the amount and shape of the portion of stained tissue to be excised will depend upon the goals of the surgery. If the surgery is purely cosmetic, then a sufficient clear area in the center of the Bowman's membrane will be excised to produce the desired appearance and to preserve the existing corneal curvature. Where the goal of the surgery is, at least in part, to correct some refractive error, then the laser parameters will be set to alter the corneal curvature.
  • the advantage of this procedure is that, when corrective surgery is to be done, at the same time, with little addition ⁇ al effort, the eye color of the patient may be changed.
  • the stain may be applied to the exposed Bowman's mem ⁇ brane 14 by conventional means.
  • a "BARRAQUER SABLE BRUSH” catalog number E0910, see page 263 of the aforementioned Storz Ophthalmic Instruments Catalog
  • a "STORZ SUPERSORB MICRO EYE SPONGE” see catalog item E0976 on page 290 of the aforementioned Storz catalog
  • a small eye dropper to apply the stain the Bowman's mem ⁇ brane 14.
  • Other suitable means will be apparent to those skilled in the art.
  • the color of the Bowman's membrane 14 and/or anterior stroma 16 is changed by a process of corneal tattooing.
  • the Bowman's membrane 14 is acellular, i.e., it is not composed of cells. Furthermore, the anterior stroma 16 disposed beneath the Bowman's membrane 14 is substantially acellular, containing few cells. The few cells which do appear in the anterior stroma 16 are substantially dormant, exhibiting little if any metabolic activity. Recent research with the excimer lasers and the results of refractive surgery indicate that the Bow ⁇ man's membrane 14 and the anterior stroma 16 can be ablated without causing structural damage to the cornea and without sacrificing its optical properties.
  • the epidermis which is commonly treated in tattooing is also substantially acellular and is composed of collagen, water, and mucopolysaccharides (as is the Bowman's membrane 14 and the corneal stroma 16).
  • the dyes commonly used in the tattooing process may also be used in applicant's process.
  • Colored tattoo pigments have been available since the end of the nineteenth century, with the predominant pigment being black India ink.
  • commercially available pigments comprise a mixture of metallic salts slurried in alcohol and glycerine.
  • the commercially available tattoo pigments are gener ⁇ ally accepted as being harmless when used in human maxillo- facial surgery and dermatology; see, e.g., H. Muller et al., "Tattooing in Maxillo-Facial Surgery,” Journal of Cranio- Maxillo-Facial Surgery, 16:382-384 (1988), and E.M. van der Velden et al., "Cosmetic tattooing as a treatment of port-wine stains," International Journal of Dermatology, 32:372-375 (1993) .
  • tattoo "cosmetic colors” are sold, e.g., by Spaulding-Rogers Manufacturing Inc. of Route 85 New Scotland Road, Voorheesville, New York 12186.
  • company cosmetic colors which are black (catalog number 8001), gray (catalog number 8002), brown (catalog number 8003), light brown (catalog numbers 8004 and 8005), dark brown (catalog number 8006), white (catalog number 8007), "cherri berri” (catalog numbers 8008 and 8009), “lemon up” (catalog numbers 8009 and 8010), banana (catalog numbers 8012 and 8013), peach (catalog numbers 8014 and 8015), fire red (catalog number 8016), dusk (catalog numbers 8018 and 8019), sandstone (catalog numbers 8020 and 8021), flesh (catalog number 8022 and 8023), salmon (catalog number 8026
  • these tattoo dyes are comprised of water-insoluble metal compounds such as hydroxides, chlorides, oxides, sulphates, or sulfides of metals such as gold, aluminum, calcium, barium, silver, or titanium.
  • water-insoluble metal compounds such as hydroxides, chlorides, oxides, sulphates, or sulfides of metals such as gold, aluminum, calcium, barium, silver, or titanium.
  • a dye is generated in situ by chemical reduction of metallic salts (e.g., gold chloride or platinum black). See, e.g., Biomedical Founda ⁇ tions of Ophthalmology, T. Duane et al. (3) 9:41.
  • metallic salts e.g., gold chloride or platinum black
  • the color of the eye is changed, in whole or in part, by a process of corneal tattooing, one preferred means of which is illustrated in Figure 7.
  • tattooing device 42 which is shown schematically, is comprised of a needle 44 comprised of an orifice 46 though which stain may be dispensed.
  • the tip 48 of needle 44 preferably has a diameter of from about 50 to about 1,000 microns and, more preferably, of less than about 500 microns (such as, e.g., from about 200 to about 500 microns; such tip 48 may be used to puncture the corneal stroma 16.
  • the tip 48 may then use such tip 48 to produce a multiplicity of punctures in that area of the exposed corneal stroma 16 which is outside of where the corneal clear area is desired to be. It is preferred that, in general, at least about 90 percent of such punctures have a maximum cross-sectional dimension (which will correspond to the maximum cross-sectional dimen ⁇ sion of tip 48) from about 20 to about 500 microns and, more preferably, from about 50 to about 250 microns. It is also preferred that, in general, at least about 90 percent of such punctures have a depth which is less than about 100 microns and, preferably, which is less than about 50 microns (and, most preferably, less than about 20 microns).
  • the punctures are created by laser energy rather than by the use of one or more needles 44.
  • this laser process it is preferred that at least about 90 percent of such laser punctures have a maximum cross-sectional dimension of from about 20 to about 500 microns and, more preferably, from about 50 to about 250 microns. It is also preferred that, in general, at least about 90 percent of such laser punctures have a depth which is less than about 100 microns and, preferably, which is less than about 50 microns (and, most preferably, less than about 20 microns).
  • the preferred laser process differs from the needle process described hereinabove in that, in the laser process, it is preferred to apply to water-insoluble stain to the area to be treated prior to the time the laser creates punctures in such area.
  • device 42 is comprised of a switch 52 which is operative- ly connected to pump 54 which, in turn, is hydraulically connected to reservoir 50.
  • flow meter 56 By reference to flow meter 56, one can monitor the amount of fluid dispensed into each puncture site.
  • more than one device 42 can be used in the process, more than one stain may be delivered to some or all of the puncture sites, and one may create puncture sites of different sizes or of the same size.
  • the device 42 may be connected to a multiplicity of needles (see Figure 9) arranged in a desired circular pattern to impress stain around a central clear corneal area; such a device in il ⁇ lustrated in Figures 9 and 10.
  • the multi ⁇ plicity of needles may be so configured and disposed that they simultaneously inject all points desired to create the pattern illustrated in Figure 8.
  • the device may be comprised of means for delivering different amounts of dye and/or different dyes and/or dye(s) at differ ⁇ ent flow rates to various of the needles.
  • the color at various points of the corneal treat ⁇ ment zone may be varied at will.
  • Figure 8 is a sectional view of mask 60 which may be used in the process of Figure 3.
  • mask 60 preferably consists essentially of a plastic material which is transparent, such as transparent polymethylmethacrylate.
  • the mask 60 is adapted to fit over the cornea 22 of an eye (see Figure 2); and many different mask 60's, each with a differently sized clear area and/or a different curvature and/or a different number of orifices and/or a different size of orifices may be used.
  • mask 60 is comprised of a central corneal clear area 62, which generally will be from about 2 to about 8 millimeters in diameter. This central clear area 62 will serve the function of a mask.
  • the mask 60 also is comprised of a multiplicity of orifices 64 through which the needle 44 (see Figure 7) may be placed.
  • needle 44 may be placed through one of said orifices 64. It is generally preferred to insert needle 44 within the cornea 22 to a depth of less than about 100 microns and, preferably, less than about 50 microns. In one preferred embodiment, the depth of puncture is less than about 20microns. As will be apparent to those skilled in the art, different punctures may be made to different depths or the same depth; and the same or different amounts and/or types of stain may be delivered to different punctures.
  • the mask 60 may contain orifices 64 of different di ⁇ mensions, and different portions of the mask may have differ ⁇ ent densities of such orifices 64. In general, from about 20 to about 100 percent of the unmasked portion of mask 60 (which is all of the mask 60 with the exception of section 62) is defined by a multiplicity of orifices 64.
  • Figure 9 is a side view of a device 70 for simultane ⁇ ously applying dye to a multiplicity of points within the corneal stroma 16.
  • This device 70 is connected via chamber 72 to pump 54 (not shown in Figures 9 and 10) which, in turn, is connected to reservoir 50 (not shown in Figures 9 and 10).
  • the bottom portion of device 70 is comprised of a curved surface 74 which has a curvature similar to the curvature of the outer clear area 22 of eyeball 10 (see Figure 1).
  • a central area 76 on the bpttom portion of device 70 which contains no needles 44; this central area 76 is adapted to designed to be aligned with the corneal clear zone 25 (see Figures 5 and 6).
  • the peripheral area 78 of the bottom portion of device 70 is comprised of a multiplicity of needles 44 which, prefer ⁇ ably, each have substantially the same depth.
  • each of the needles 24 will penetrate the eyeball 10 to substantially the same extent.
  • Each of the needles 44 is comprised of an orifice 46 and a needle tip 48 (not shown in Figure 9, but see Figure 7).
  • each of the orifices 46 is of substantially the same size.
  • a variety of techniques may be used to provide a clear zone in the cornea centrally.
  • One option is the use of the laser to ablate a central area and provide a clear path for vision.
  • a mask may be utilized to prevent the dye from stain ⁇ ing the central corneal area.
  • a neutralization agent may be employed to clear the visual axis.
  • a technique for performing a lamellar keractectomy and dissecting a pocket within the corneal stroma.
  • a disc of artificial material of a given power is then placed in this space.
  • the disc may be manufactured to correct nearsightedness or farsightedness as well as astigmatism.
  • the disc can be tinted in a manner similar to that used with contact lenses to mask or alter the color of the underlying stroma.
  • a central clear zone may be incorporated to maintain normal vision and appearance and to thereby produce a natural looking change in the color of the iris.
  • the process can also be applied to patients undergoing automated lamellar keratoplasty (ALK) or in situ keratomileu- sis.
  • Either the corneal surface or the corneal button may be stained with available dyes.
  • a central clear zone would be maintained either via the method of application of dye to the corneal stroma or by applying the dye prior to shaving of the corneal tissue.
  • the central area removed can also have remov ⁇ al of the dyed corneal tissue.
  • a laser beam energy is used to fix stain upon the target tissue.
  • This embodiment may be used in tattooing collagen tissue in general; and it is especially useful in precisely and safely effecting change of eye color in ocular tissue.
  • This process is a variation of one of the processes illustrated in Figure 3.
  • a certain portion of the stained stroma is then contacted with a pattern of laser energy adapted to fix the stain the collagen tissue in such stroma only in said pattern (see step 43); alternatively, or additionally, this procedure may be applied to the Bowman's membrane.
  • the stain thus contacted by the laser energy is permanently bonded to the collagen target tissue.
  • the stain not contacted by the laser energy is removed by washing in step 45.
  • the cross-sectional size of the puncture wounds made by the laser process will be substantially identical to the cross-sectional size of the puncture wounds made by the needle process.
  • the depth of the puncture wounds made by the laser process will be substantially identical to the depth of the puncture wounds made by the needle process.
  • the width of the puncture wounds made by the laser process will be substantial ⁇ ly identical to the width of the puncture wounds made by the needle process.
  • each puncture be separated from each adjacent puncture by from about 10 to about 1,000 microns and, more preferably, from about 20 to about 500 microns. It is also preferred that the maximum cross-sectional dimension of each puncture, on average, be from about 20 to about 500 microns and, more preferably, be from about 50 to about 250 microns.
  • the depth of penetration of each puncture is less than 100 microns and, preferably, less than about 50 microns. In one especially preferred embodiment, the average depth of penetration of each puncture is less than about 20 microns.
  • laser energy with a wavelength above 300 nanometers, preferably within the range of from about 300 to about 1,064 nanometers.
  • the wavelength of the laser energy used is from about 450 to about 650 nanometers.
  • the advantage of the use of such laser energy is that, with modern opthamological lasers, one is able create punctures with specified depths of penetration, cross-sectional sizes, and degrees of separation and to fix the stain in a speci ⁇ fied, predetermined pattern (which, for example, can corre ⁇ spond to the mask of Figure 8) using a specified amount of energy for a specified amount of time; see, e.g.. Figure 11, in which a multiplicity of laser beams 84 contacts the stained corneal stroma in a concentric area outside of the clear zone 76.
  • This laser system pro ⁇ prises a beam of infrared light at a wavelength of 1053 nanome ⁇ ters. It can produce such beam of light in a desired pattern, such as a circle (see page 4.15 of the operator's manual), a spiral (see page 4.17 of manual), and the like. Thus, refer ⁇ ring to page 4.17 of such manual, "The spiral pattern moves the beam in a three-dimensional series of ever increasing (or decreasing) concentric circles. The completed pattern resem ⁇ bles a disc. "
  • the amount of energy emitted per pulse may be varied from about 40 to about 350 microjoules.
  • the spot size may be varied by overlaying laser pulses (see page 4.4 of the manual).
  • selection of the laser retinal im ⁇ age size is accomplished by rotating the Spot Size Selector ring.
  • the spot size is continuously adjustable from 50 to 2,000 microns.
  • the spot sizes are clearly marked on the se ⁇ lector ring and their locations are fixed by detents.
  • the System 900 is also comprised of a laser tele ⁇ scope/manipulator assembly. This micromanipulator enables precise placement of each lesion.
  • the laser power output of the System 900 can be set from 0 to 2.0 watts at the cornea and is continuously adjust ⁇ able over this range.
  • the laser exposure time can be set for 0.02, 0.05, 0.1, 0.2, 0.5, 1, 2, or 5 seconds.
  • the depth of penetration of the lesions created by the laser can be varied by varying the power output and/or the exposure time.
  • the laser is first used to pierce the epithelium, preferably in a predetermined pattern. Stain is then applied to the multiplicity of punctures thus formed by conventional means, such as the means described elsewhere in this specification. Thereafter the laser is used to bond the dye to the underlying tissues. Tattooing of skin
  • laser energy in a certain pat ⁇ tern is used to provide a multiplicity of punctures within the skin. Thereafter, stain is topically applied and fixed to the skin by a second application of laser energy.
  • an argon laser sys ⁇ tem (a "System 900 Photocoagulator with Argon Laser and Zeiss Slit Lamp", which is sold by the Coherent Radiation Company of 3270 West Bayshore Road, Palo Alto, California 94303) was used.
  • a laser wavelength of 440 nanometers was used, with a 2.0 second exposure time, a 500 micron spot size, and an energy level of 0.5 watts. This laser energy was applied two times to each spot in the cornea where a puncture was desired.
  • the rabbits were first euthanized and then, within two minutes, the eyes of each rabbit were removed intact by surgical enucleation means.
  • a 38.1 millimeter Barraquer wire speculum obtained from Xomed-Treace Company of Jacksonville, Florida was carefully placed in each eye, and about 0.5 milliliters of a sterile balanced salt solution (obtained from IOLAB Pharmaceuticals of Claremont, California) were dropped into the eye to keep it moist.
  • the eye was held with a 0.3 millimeter Colibri corneal utility forceps (obtained from the Storz Instrument Company of St.
  • each of the eyes was placed in a Petri dish under a Topcon OMS-70 operating microscope manufactured by the Tokyo Optical Company of Japan.
  • the balanced salt solution was dropped on the eye to keep it moist, and the eye was then marked with a 6.5 milli ⁇ meter disposable trephine (available from the Storz Instrument Company) .
  • the corneal epithelium was removed from the surface with a surgical curette (a No. 3, 2.5 millimeter cup Meyer- hoefer Chalazion curette available from the Storz Instrument Company) by scraping until fluorescein strips (obtained from IOLAB Pharmaceuticals of Claremont, California) indicated that the entire epithelium had been removed.
  • About 0.5 milliliters of the balanced salt solution was dropped onto the tip of the fluorescein strip, the excess was rinsed and then absorbed with surgical sponge spears (manufactured by Katena Products Inc.
  • the surface of the corneal stroma was then cleansed by irrigating with 0.9 volume percent normal saline solution and was dried with the Katena sponge spears by wiping the surface.
  • a ring of Chloromycetin ophthalmic ointment (manufac ⁇ tured by the Parke Davis Corporation of Morris Plains, New Jersey, N0071-3070-07) was placed on the corneal stroma in a ring-like fashion at the external perimeter of the cornea, thereby creating a dam encompassing approximately 100 square millimeters of corneal surface area, thereby preventing the applied dye from running off the cornea and maintaining con ⁇ tact between the dye and the corneal surface.
  • a 0.5 ounce bottle of black "cosmetic color” dye was obtained (as catalog number 8001) from the Spaulding-Rogers Manufacturing company of Route 85 New Scotland Road, Vorhees- ville. New York 12186.
  • One milliliter of this colorant was drawn into a Terumo "NEOLUS” syringe (0.050 x 16 millimeters, with a tuberculin needle), manufactured by the Terumo Corpora ⁇ tion of Tokyo, Japan.
  • the eyes were removed from the laser, the ointment around the perimeter of the eyes was removed with a sponge, and the eye surfaces were again irri ⁇ gated with about 1 cubic centimeter of the 0.9 volume percent normal saline solution.
  • Corneal specimens were prepared in standard fashion for examination by light microscopy and scanning electron microscopy.
  • the tissues were examined under a scanning electron microscope (model number EM902, available from the Carl Zeiss, Inc of One Zeiss Drive, Thornwood, New York 10594. It was found that the black pigment was fixed within the corneal tissue. Even after such tissue was washed, the spots treated by the laser were clearly marked with pigment.
  • Example 3 The procedure of Example 1 was substantially repeated with the exception that, instead of the black dye, gray dye (catalog number 8002, obtained from the Spaulding-Rogers Manufacturing company) was used. Similar results were ob ⁇ tained, the gray dye being securely fixed within the corneal tissue.
  • gray dye catalog number 8002, obtained from the Spaulding-Rogers Manufacturing company
  • Example 4 The procedure of Example 1 was substantially repeated with the exception that, instead of the black dye, brown dye (catalog number 8003, obtained from the Spaulding-Rogers Manufacturing company) was used. Similar results were ob ⁇ tained, the brown dye being securely fixed within the corneal tissue.
  • brown dye catalog number 8003, obtained from the Spaulding-Rogers Manufacturing company
  • Example 1 The procedure of Example 1 was substantially repeated with the exception that, instead of the black dye, fire red dye (catalog number 8016, obtained from the Spaulding-Rogers Manufacturing company) was used. Similar results were ob ⁇ tained, the fire red dye being securely fixed within the corneal tissue.
  • fire red dye catalog number 8016, obtained from the Spaulding-Rogers Manufacturing company

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Abstract

Procédé chirurgical servant à modifier la couleur du globe oculaire chez l'homme. Dans la première étape de ce procédé, on enlève pratiquement la totalité de l'épithélium dudit globe oculaire, ce qui permet d'exposer une couche des lamelles cornéennes les plus profondes du globe oculaire. Ensuite, on applique un colorant insoluble dans l'eau à la couche desdites lamelles cornéennes et on fixe le colorant par mise en contact de ladite couche avec de l'énergie laser possédant une longueur d'ondes située entre 300 et 1.064 nanomètres environ. On lave ensuite le globe oculaire traité.
PCT/US1994/008242 1993-07-22 1994-07-22 Procede de coloration oculaire servant a modifier la couleur de l' ×il WO1995003017A1 (fr)

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005117988A1 (fr) * 2004-06-01 2005-12-15 Glazier Alan N Conjugues de pigment de couleur d'anti-corps pour le changement de l'apparence de la couleur de l'oeil
US7003447B1 (en) 1998-09-23 2006-02-21 British Broadcasting Corporation Tandem audio compression
WO2018224791A1 (fr) * 2017-06-07 2018-12-13 Neoris Dispositifs et procédé de préparation et de réalisation de tatouages cornéens
US20210275014A1 (en) * 2015-11-06 2021-09-09 William F. WILEY Device and method for marking the cornea
FR3117335A1 (fr) * 2020-12-14 2022-06-17 Georges Baikoff Procédé de coloration de la cornée
EP4574112A1 (fr) * 2023-12-21 2025-06-25 Ziemer Ophthalmic Systems AG Système ophtalmologique pour l'élimination par ablation de colorant oculaire

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3982541A (en) * 1974-07-29 1976-09-28 Esperance Jr Francis A L Eye surgical instrument
US4461294A (en) * 1982-01-20 1984-07-24 Baron Neville A Apparatus and process for recurving the cornea of an eye
EP0151869A2 (fr) * 1983-11-17 1985-08-21 L'Esperance, Francis A. Dispositif de chirurgie ophtalmologique
US4712543A (en) * 1982-01-20 1987-12-15 Baron Neville A Process for recurving the cornea of an eye

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3982541A (en) * 1974-07-29 1976-09-28 Esperance Jr Francis A L Eye surgical instrument
US4461294A (en) * 1982-01-20 1984-07-24 Baron Neville A Apparatus and process for recurving the cornea of an eye
US4712543A (en) * 1982-01-20 1987-12-15 Baron Neville A Process for recurving the cornea of an eye
EP0151869A2 (fr) * 1983-11-17 1985-08-21 L'Esperance, Francis A. Dispositif de chirurgie ophtalmologique

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7003447B1 (en) 1998-09-23 2006-02-21 British Broadcasting Corporation Tandem audio compression
WO2005117988A1 (fr) * 2004-06-01 2005-12-15 Glazier Alan N Conjugues de pigment de couleur d'anti-corps pour le changement de l'apparence de la couleur de l'oeil
US20210275014A1 (en) * 2015-11-06 2021-09-09 William F. WILEY Device and method for marking the cornea
WO2018224791A1 (fr) * 2017-06-07 2018-12-13 Neoris Dispositifs et procédé de préparation et de réalisation de tatouages cornéens
FR3117335A1 (fr) * 2020-12-14 2022-06-17 Georges Baikoff Procédé de coloration de la cornée
WO2022129759A1 (fr) * 2020-12-14 2022-06-23 Georges Baikoff Composition de coloration de la cornée
EP4574112A1 (fr) * 2023-12-21 2025-06-25 Ziemer Ophthalmic Systems AG Système ophtalmologique pour l'élimination par ablation de colorant oculaire

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